MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EB217, VOYANT MARYLAND FUSION 23CM, 6/BX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EB217
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: wide local excision.Event description: it was noticed during the case that there were a few significant red marks (potential burn) to the skin next to the incision under the armpit.The surgeon made sure that the voyant jaws / metal section between jaws and plastic shaft were not in contact with this section of skin at any point during the case.The only part of the voyant device that came into contact with the skin was the plastic shaft.They were taking the sentinel nodes at the time the mark was seen.Unfortunately, the cable was cut off the device so was not able to be returned.I was not allowed to take a picture (trust policy) of the marks, but i have drawn a diagram of what it looked like.The larger incision is 2mm wide x 12mm long and the 2 smaller marks were 3mm wide x 4mm long.Additional information received from applied medical representative via email 18oct22: patient is okay, the surgeon couldn¿t really resolve the situation, they closed the incision as normal and the injury/mark will need to looked at to make sure it doesn¿t get any worse.Intervention: the surgeon couldn¿t really resolve the situation, they closed the incision as normal and the injury/mark will need to looked at to make sure it doesn¿t get any worse.Patient status: patient is okay.
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: wide local excision.Event description: it was noticed during the case that there were a few significant red marks (potential burn) to the skin next to the incision under the armpit.The surgeon made sure that the voyant jaws / metal section between jaws and plastic shaft were not in contact with this section of skin at any point during the case.The only part of the voyant device that came into contact with the skin was the plastic shaft.They were taking the sentinel nodes at the time the mark was seen.Unfortunately, the cable was cut off the device so was not able to be returned.I was not allowed to take a picture (trust policy) of the marks, but i have drawn a diagram of what it looked like.The larger incision is 2mm wide x 12mm long and the 2 smaller marks were 3mm wide x 4mm long.Additional information received from applied medical representative via email (b)(6)2022: patient is okay, the surgeon couldn¿t really resolve the situation, they closed the incision as normal and the injury/mark will need to looked at to make sure it doesn¿t get any worse.Intervention: the surgeon couldn¿t really resolve the situation, they closed the incision as normal and the injury/mark will need to looked at to make sure it doesn¿t get any worse.Patient status: patient is okay.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.

• Brand Name: EB217, VOYANT MARYLAND FUSION 23CM, 6/BX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15696972
• Report Number: 2027111-2022-00791
• Device Sequence Number: 17847933
• Product Code: GEI
• UDI-Device Identifier: 00607915139377
• UDI-Public: (01)00607915139377(17)250406(30)01(10)1449493
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K200598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2025
• Device Model Number: EB217
• Device Catalogue Number: 101475458
• Device Lot Number: 1449493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown